Learning Marketplace

Medical Device Single Audit Program (MDSAP) for Manufacturers

The International Medical Device Regulators Forum (IMDRF) has recognized the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure patient safety. The IMDRF, at its inaugural meeting in Singapore in 2012, identified a Work Group to develop specific documents for advancing the concept of the Medical Device Single Audit Program (MDSAP).

This webinar will cover what is involved in the program, including what manufacturers can expect:

  • Main differences in your current audits and audits conducted under MDSAP
  • Explanation of grading non-conformities
  • Unannounced Audits
  • Audit structure/plan
  • Submitting reports to the regulators and their role in MDSAP
  • Opting out of regulations
  • Potential witness audits by the regulators

Who should attend

  • Regulatory Affairs Professionals
  • Quality Assurance Professionals
  • Medical Device Sales and Marketing